BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2950568 · Received February 5, 2013

    Report

    Report Number
    1423337-2013-00004
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, LEICA MICROSYSTEMS RECEIVED INFORMATION FROM THE ORGANIZATION REGARDING THE FINAL STATUS OF TISSUE SAMPLES PROCESSED IN THE THREE (3) "2HR XYLENE FREE/FORMALIN" PROTOCOLS FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE COMPLAINANT. THE INFORMATION RECEIVED STATED THAT THE PATHOLOGIST WAS UNABLE TO RENDER A DIAGNOSIS FOR THE TISSUE SAMPLES FROM 10 PATIENTS, AND THAT AS A CONSEQUENCE RE-BIOPSY OF THIS PATIENT WAS CONDUCTED ON (B)(6) 2012. PLEASE REFER TO MFR. REPORT # 8020030-2012-00064 FOR INFORMATION RELATED TO THE INSTRUMENT AND INITIAL COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49176 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention